In 1996 The University of Rochester was offering $150 to volunteers for what was designed to be a minimal-risk research study. To 19-year-old Nicole (
The study was focused on the mechanism by which the lungs defend against infection and pollutants. Participants underwent a bronchoscopy that allowed researchers to retrieve a sample of lung cells. This routine procedure was initiated by administering up to 5 milligrams per milliliter of an anesthetic called Lidocaine, per the
The tragic and untimely passing of Nicole Wan prompted an onset of ethical questions regarding clinical research:
- Should invasive clinical research procedures have more stringent age requirements?
- Should they be required to follow the same FDA guidance (Table 1) that has been developed for clinical research devices in pediatrics?
- Is it ethical to advertise compensation-based research studies to college students between the ages of (18-21) considering the average student’s financial circumstances?
- Are those conducting the research procedures equipped with the proper training?
- Are the researchers’ training/credentials being routinely monitored?
|Pediatric Subgroup||Approximate Age Range|
|From birth to 1 month of age|
|Infant||Greater than 1 month to 2 years of age|
|Child||Greater than 2 to 12 years of age|
|Adolescent||Greater than 12 through 21 years of age|
The above is the most current FDA guidance describing pediatric populations divided into the listed subgroups.
Clinical research studies are essential for the progression of human health. The foundation of this progression is entirely dependent on the willingness of brave participants like Nicole Wan. It is the responsibility of all research personnel including the sponsors, investigators,